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FDA 510(k)

VR® Personal Protective Level 4 Gown (VR Gowns)

K-Number: K261115 · 2026-08-11

ApplicantPolyConversions, Inc.
Decision Date2026-08-11
Product CodeQPC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VR® Personal Protective Level 4 Gown (VR Gowns) is the device name listed in this FDA 510(k) record. The listed applicant is PolyConversions, Inc.. It received FDA 510(k) clearance on 2026-08-11 under 510(k) number K261115. The device is classified under product code QPC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VR® Personal Protective Level 4 Gown (VR Gowns)?

VR® Personal Protective Level 4 Gown (VR Gowns) is a medical device that received FDA 510(k) clearance on 2026-08-11. The listed applicant is PolyConversions, Inc.. The 510(k) number is K261115.

When did VR® Personal Protective Level 4 Gown (VR Gowns) receive FDA 510(k) clearance?

VR® Personal Protective Level 4 Gown (VR Gowns) received FDA 510(k) clearance on 2026-08-11, under 510(k) number K261115.

Who is the listed applicant for VR® Personal Protective Level 4 Gown (VR Gowns)?

The FDA 510(k) record lists PolyConversions, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VR® Personal Protective Level 4 Gown (VR Gowns)?

The FDA product code for VR® Personal Protective Level 4 Gown (VR Gowns) is QPC.

Other records listing PolyConversions, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252940VR® Personal Protective Level 3 Gown (VR Gowns)K230384PolyWear® Personal Protective Level 3 Gown

Related Devices (Code: QPC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252940VR® Personal Protective Level 3 Gown (VR Gowns)PolyConversions, Inc.K242689AAMI Level 4 Protective; GownAzac GroupK233526Medline Open-back Level 3 Protective GownMedline Industries, LPK230384PolyWear® Personal Protective Level 3 GownPolyConversions, Inc.K222128Protective Gown AAMI Level 4Kenpax International LimitedK212464Dukal Corporation AAMI Level 4 Open-Back Protective GownDukal Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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